NDC Code(s) : 0641-0493-21, 0641-0493-25, 0641-2555-41, 0641-2555-45
Packager : Hikma Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Phenytoin SodiumPhenytoin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-0493
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYTOIN SODIUM(UNII: 4182431BJH)
(PHENYTOIN - UNII:6158TKW0C5) 		PHENYTOIN SODIUM50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)0.4 mL in 1 mL
ALCOHOL(UNII: 3K9958V90M)0.1 mL in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-0493-2525 in 1 CARTON 16/07/1975
1NDC:0641-0493-212 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084307 07/16/1975
Phenytoin SodiumPhenytoin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-2555
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYTOIN SODIUM(UNII: 4182431BJH)
(PHENYTOIN - UNII:6158TKW0C5) 		PHENYTOIN SODIUM50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)0.4 mL in 1 mL
ALCOHOL(UNII: 3K9958V90M)0.1 mL in 1 mL
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0641-2555-4525 in 1 CARTON 16/07/1975
1NDC:0641-2555-415 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084307 07/16/1975

LABELER - Hikma Pharmaceuticals USA Inc.(946499746)

PRINCIPAL DISPLAY PANEL

NDC 0641-0493-21          Rx only
Phenytoin
 Sodium Inj., USP
100 mg per 2 mL
(50 mg/mL)
For IV or IM use
Do not use if hazy or
has a precipitate
2 mL Single Dose Vial

vial

NDC 0641-0493-25         Rx only
Phenytoin
 Sodium Injection, USP
100 mg per 2 mL
 (50 mg/mL)          
For Intravenous
or Intramuscular use
25 x 2 mL Single Dose Vials

vial

PRINCIPAL DISPLAY PANEL

NDC 0641-2555-41        Rx only
Phenytoin
 Sodium Inj., USP
250 mg per 5 mL
 (50 mg/mL)
 For IV or IM use
5 mL Single Dose Vial

vial

NDC 0641-2555-10        Rx only
Phenytoin
 Sodium Injection, USP
250 mg per 5 mL
 (50 mg/mL)
For Intravenous
or Intramuscular use
10 x 5 mL Single Dose Vials

vial

PRINCIPAL DISPLAY PANEL

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